Eu Ivdd
Eu Ivd General
On The Market
🇺🇸 United States
Control Kit - GC3ab L5-L6
Devices (same UDI-DI)
1
Certificates
1
Countries
0
Notified Bodies
1
Basic Information
- Primary DI
- 00850011135426
- Basic UDI-DI Code
- B-00850011135426
- Reference
- 92-001002-00
- Device Types
-
Single use
- Regulation
- Eu Ivdd
- Classification
- Eu Ivd General
- Status
- On The Market
- Manufacturer
- LGC Clinical Diagnostics, Inc.
Additional Description
This product is intended for use as an unassayed internal quality control to monitor the precision of laboratory testing procedures for the following analytes: alkaline phosphatase (ALP), alanine aminotransferase (ALT), amylase (AMY), aspartate aminotransferase (AST), creatine kinase (CK), gamma - glutamyl transferase (GGT), lactate dehydrogenase (LD) and lipase (LIP).
CND Nomenclature Codes
| Code | Description |
|---|---|
| W0101050101 | ASSAYED MULTICOMPONENT CONTROLS (CC) |
| W0101050102 | UNASSAYED MULTICOMPONENT CONTROLS (CC) |
Certificates
| Type | Number | Notified Body | Status |
|---|---|---|---|
| IVDD Annex IV (excluding sections 4, 6) | 3822623 | DEKRA Certification B.V. | Expired |
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